small molecule

SUBOXONE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Loss of exclusivityMarch 2030latest FDA-listed patent expiry
CompanyIndiviorSee this company's full patent-cliff portfolio

Drug detail

Brand nameSUBOXONE
Active ingredientBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
StrengthEQ 4MG BASE;EQ 1MG BASE
Dosage formFILM
RouteBUCCAL, SUBLINGUAL
ModalitySmall molecule
FDA approvalAugust 2012
Marketing statusRX

Listed patents

PatentExpiresType
8475832March 2030product
9687454August 2029product
11135216August 2029product

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

SUBOXONE patent cliff — loss of exclusivity March 2030 | CliffBio